K Number
K212544
Device Name
MiniLoad Syringe
Manufacturer
Date Cleared
2021-10-13

(62 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
Device Description
The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
More Information

MiniLoad Syringe (K202432)

PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)

No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML.

No.
A syringe is a medical device used for injecting or withdrawing fluids, which are procedures, rather than being a therapeutic device that directly treats a condition or disease.

No

The device is described as facilitating injections or fluid withdrawal, which are therapeutic or procedural actions, not diagnostic ones. There is no mention of it being used to analyze or identify medical conditions.

No

The device description clearly outlines physical components (hollow barrel, plunger, slip tip/luer-lock ends) and the performance studies focus on physical and material properties, not software functionality.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "to facilitate injections into or withdraw fluids from the body." This describes a device used for direct interaction with the body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
  • Device Description: The description details a syringe for fluid injection and aspiration, which is a common medical device used for administering substances or collecting samples directly from a patient.
  • Lack of IVD Characteristics: There is no mention of:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information about a patient's health status based on sample analysis
    • Reagents or other components typically associated with IVD tests

The device described is a standard medical syringe used for procedures like administering medication, drawing blood, or aspirating fluids. These are not considered in vitro diagnostic activities.

N/A

Intended Use / Indications for Use

The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

Product codes (comma separated list FDA assigned to the subject device)

FMF

Device Description

The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following performance data are available in support of the substantial equivalence.

  • Freedom from Extraneous Matter (ISO 7886-1)
  • Lubricant Quantification (ISO 7886-1)
  • Plunger Stop Detachment (ISO 7886-1)
  • Barrel Flange to Plunger Distance (ISO 7886-1)
  • Dead Space (ISO 7886-1)
  • Freedom from leakage (ISO 7886-1)
  • Piston operational force (ISO 7886-1)
  • Plunger Fit (ISO 7886-1)
  • Luer connector (ISO 80369-7)
  • Biocompatibility [External communicating device Blood path indirect; limited (

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).

0

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October 13, 2021

OcuJect, LLC Rebecca Pine Official Correspondent 1441 Avocado Ave, Suite 204 Newport Beach, California 92660

Re: K212544

Trade/Device Name: MiniLoad Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: September 13, 2021 Received: September 15, 2021

Dear Rebecca Pine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Alans Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K212544

Device Name MiniLoad Syringe

Indications for Use (Describe)

The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K212544 510(k) Summary

SUBMITTER I.

OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660

Contact person: Rebecca K Pine Phone: (760) 809-5178 Fax: (760) 290.3216 Date prepared: October 13, 2021

II. DEVICE

Name of the device: MiniLoad® Syringe Common of usual name: Syringe Classification name: Syringe, Piston Regulatory Class: II Product Code: FMF Regulation: 21 CFR 880.5860

  • III. PREDICATE DEVICE MiniLoad Syringe (K202432)- primary predicate
    PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)- reference device

  • IV. DEVICE DESCRIPTION The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.

  • V. INDICATIONS FOR USE The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

  • VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the modified MiniLoad Syringe are highly analogous to the technological characteristics of the cleared MiniLoad Syringe (K202432).

The similarities and differences are illustrated in the table below:

4

Subject devicePrimary PredicateComparison
MiniLoad Syringe
SyringeMiniLoad Syringe
(K202432)
Proprietary NameMiniLoad SyringeMiniLoad Syringe
Product CodeFMFFMF
IndicationsThe MiniLoad
Syringe is used to
facilitate injections
into or withdraw
fluids from the bodyThe MiniLoad
Syringe is used to
facilitate injections
into or withdraw
fluids from the
bodySAME
Intended UsersCliniciansCliniciansSAME
Principle of operationManual
advancement and
withdrawal of the
plunger within the
barrelManual
advancement and
withdrawal of the
plunger within the
barrelSAME
Device componentsSyringe
Barrel
PlungerSyringe
Barrel
PlungerSAME
Materials BarrelPolypropylene
BorMed HF840MO
Cas # 9300-07-0Polypropylene
GM1600ESAME
PlungerPolyethylene
blue pigment
P83424Polyethylene
blue pigment
P83424SAME
LubricantOleamideOleamideSAME
Barrel Size Volume(ml)1mL1mLSAME
Barrel length~ 85mm~ 85mmSAME
Barrel outside
diameter~ 6.4mm~ 6.4mmSAME
Barrel inside
diameter~ 4.6mm~ 4.6mmSAME
Barrel colorTransparentTransparentSAME
Barrel printingBlack inkBlack inkSAME
Plunger length93.4 mm
85.3 mm93.4 mmDifference
#..1
Plunger colorBlueBlueSAME
GraduationPrinted, ISO 7886-1
compliantPrinted, ISO 7886-1
compliantSAME
Tip typeLuer slip
Luer lockLuer slipDifference
#2
Dead space
specification$\leq$ 0.023mL with
95%
confidence/95%
reliabilityISO 7886-1
compliantDifference
#3
Sterilization methodEOEOSAME
SAL10-610-6SAME
Sterilization
Validation StandardISO 11135-1ISO 11135-1SAME
Subject devicePrimary PredicateComparison
MiniLoad SyringeMiniLoad Syringe
(K202432)
Syringe
BiocompatibilityISO 10993-1
(Biological
Evaluation)ISO 10993-1
(Biological
Evaluation)SAME
ISO 10993-4ISO 10993-4
(Hemocompatibilty)(Hemocompatibilty)
ISO 10993-5
(cytotoxicity)ISO 10993-5
(cytotoxicity)
ISO 10993-7 (EO
residuals)ISO 10993-7 (EO
residuals)
ISO 10993-10 (
Sensitization)ISO 10993-10 (
Sensitization)
ISO 10993-10
(Irritation,
Acute Systemic
Toxicity (ISO
10993-11)ISO 10993-10
(Irritation,
Acute Systemic
Toxicity (ISO
10993-11)
Materials Mediated
Pyrogenicity (ISO
10993-10)Materials Mediated
Pyrogenicity (ISO
10993-10)
Performance DataISO 7886-1
ISO 83069-7

5

Difference #1: The subject device has a shorter plunger length. Differences addressed through testing per ISO 7886-1:2017.

Difference #2: The subject device has a luer lock connector. Differences addressed through testing per ISO 80369-7.

Difference #3: Subject device has dead space specification of